Fassier-Duval Telescopic IM System

Rod, Fixation, Intramedullary And Accessories

Pega Medical Inc.

The following data is part of a premarket notification filed by Pega Medical Inc. with the FDA for Fassier-duval Telescopic Im System.

Pre-market Notification Details

Device IDK211292
510k NumberK211292
Device Name:Fassier-Duval Telescopic IM System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant Pega Medical Inc. 1111 Autoroute Chomedey Laval,  CA H7w 5j8
ContactEnrique Garcia
CorrespondentEnrique Garcia
Pega Medical Inc. 1111 Autoroute Chomedey Laval,  CA H7w 5j8
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-28
Decision Date2021-05-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07540194013422 K211292 000
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07540194013255 K211292 000
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07540194013217 K211292 000
07540194013200 K211292 000
07540194013194 K211292 000
07540194013293 K211292 000
07540194013309 K211292 000
07540194013316 K211292 000
07540194013415 K211292 000
07540194013408 K211292 000
07540194013392 K211292 000
07540194013385 K211292 000
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07540194013361 K211292 000
07540194013354 K211292 000
07540194013347 K211292 000
07540194013330 K211292 000
07540194013323 K211292 000
07540194013187 K211292 000

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